UMIN-CTR Clinical Trial

Basic information
Public title	Feasibility study of internet-based guided self-help cognitive behavioral therapy for workers with subthreshold depression
Acronym	Stress check study
Scientific Title	Feasibility study of internet-based guided self-help cognitive behavioral therapy for workers with subthreshold depression
Scientific Title:Acronym	Stress check study
Region	Japan

Condition
Condition	subthreshold depression
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the safety and efficacy of the internet-based guided self-help cognitive behavioral therapy with subthreshold depression
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I,II

Assessment
Primary outcomes	The Center for Epidemiological Studies Depression scale (CES-D)
Key secondary outcomes	1. Beck Depression Inventory-II (BDI-II) 2. General Health Questionnaire-12 (GHQ12) 3. QOL (EQ-5D-5L) 4. Sheehan Disability Scale (SDISS) 5. Presenteeism (Stanford Presenteeism Scale (SPS) 6. Cognitive Control Scale 7. Quick Inventory of Depressive Symptomatology (QIDS-J) 8. Session Rating Scale (SRS) 9. Onset of depressive disorders at the 36 weeks follow-up

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Internet-based guided self-help cognitive behavioral therapy
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	66 years-old >
Gender	Male and Female
Key inclusion criteria	1. Workers with high stress-related symptoms and conditions assessed by the Stress Check Test 2. The Center for Epidemiological Studies-Depression (CES-D) > = 16 at the baseline 3. Age 20 years or older, and 65 years or younger at the baseline 4. Subjects who give full consent in the participation of the study
Key exclusion criteria	1. Subjects with current DSM-IV major depressive disorder or during treatment for depression at the baseline 2. Subjects with manic episode or psychotic disorders or during treatment for bipolar disorder or psychotic disorders at the baseline 3. During treatment with antidepressant, mood stabilizer or antipsychotics at the baseline 4. Serious suicidal ideation at the baseline 5. Structured psychotherapy during the intervention 6. Other relevant reason decided by the investigators
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Reiji Middle name Last name Yoshimura
Organization	University of Occupational and Environmental Health, Japan
Division name	Department of Psychiatry
Zip code	807-0804
Address	1-1, Iseigaoka, Yahatanishi-ku Kitakyushu-shi, Fukuoka, 807-0804, Japan
TEL	093-691-7253
Email	yoshi621@med.uoeh-u.ac.jp

Public contact
Name of contact person	1st name Kensuke Middle name Last name Utsunomiya
Organization	University of Occupational and Environmental Health, Japan
Division name	Department of Psychiatry
Zip code	807-0804
Address	1-1, Iseigaoka, Yahatanishi-ku Kitakyushu-shi, Fukuoka, 807-0804, Japan
TEL	093-691-7253
Homepage URL
Email	k-utsu@med.uoeh-u.ac.jp

Sponsor
Institute	University of Occupational and Environmental Health, Japan
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor	Keio University School of Medicine
Name of secondary funder(s)

IRB Contact (For public release)
Organization	University of Occupational and Environmental Health, Japan
Address	1-1, Iseigaoka, Yahatanishi-ku Kitakyushu-shi, Fukuoka, 807-0804, Japan
Tel	093-691-7205
Email	daigakukanri@mbox.pub.uoeh-u.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 09 Month 19 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2017 Year 08 Month 25 Day
Date of IRB	2017 Year 09 Month 05 Day
Anticipated trial start date	2017 Year 09 Month 19 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 09 Month 19 Day
Last modified on	2022 Year 09 Month 15 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033366